Environmental Factors Associated with Professional Misconduct in Medical Research and Practice

Abstract

“Ethical disasters” in medicine—that is, egregious violations of professional ethics—often receive significant publicity, which feeds mistrust of the medical system, which in turn discourages participation in medical research and access to health care. Well-known examples of ethical disasters in medical research include the Tuskegee syphilis study, the death of Jesse Gelsinger in a non-therapeutic genetic experiment, and U.S. government radiation experiments on patients.

The U.S. government and professional organizations have taken steps to reduce the prevalence of ethical disasters. These steps include: disclosure and management of conflicts of interest; mandates for ethics education; and the establishment of review and oversight committees (such as institutional review boards (IRBs), data and safety monitoring boards, and patient safety committees).

However, some data indicate that these policies are questionably effective in achieving their aims. In part, this is because they ignore psychological data indicating that certain personality factors (such as cynicism and narcissism) strongly correlate with unprofessional behavior. More importantly for the purposes of this study, they inadequately address fundamental characteristics of the medical environment that may enable or encourage unprofessional behavior. Less is known about these environmental factors than may be commonly assumed. We have found no articles that systematically review data on a broad range of environmental influences on misbehavior in medicine (akin to Trevino’s review article on general organizational misbehavior). Moreover, while historical studies have been published on significant cases (e.g., the Tuskegee study), we have found no meta-analysis of such cases, no studies examining patterns across ethical disasters.

In this study, we review and gather data that informs our policy responses to professional misbehavior in medicine and medical research, providing an evidence base for improving ethics education, addressing conflicts of interest, and providing oversight. This is accomplished through an original historiometric study of cases of “ethical disasters” in medical care and research which will aim to determine what contextual or environmental variables are correlated with professional misbehavior in medical care and research.